The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

16651–16675 of 21645

  • ModerateFDA (Devices)·Z-1347-2015·2015-04-08

    Microtek Medical Smoke Evacuator Tube Sets Recalled for Latex Packaging

    Microtek Medical Inc is recalling sterile smoke evacuator tube sets because the packaging contains latex without the required warning label.

    Product
    (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1648-2015·2015-04-08

    Health One Pharmaceuticals Recalls Yin Vive Dietary Supplement

    Health One Pharmaceuticals is recalling Yin Vive dietary supplements due to significant violations of cGMP regulations.

    Product
    Yin Vive, 80 Veggie Capsules, 400mg
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1375-2015·2015-04-08

    BD Biosciences Recalls CD123 PE Reagent Due to Antibody Contamination

    BD Biosciences is recalling one lot of CD123 PE reagent because it contains a low amount of CD4 antibody, which may result in unexpected staining patterns.

    Product
    CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1360-2015·2015-04-08

    Zimmer Recalls Persona Anterior Referencing Sizers Due to Specification Nonconformance

    Zimmer, Inc. is voluntarily recalling 22 lots of Persona Anterior Referencing Sizers with Locking Boom because the devices do not conform to print specifications.

    Product
    Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer…
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Food)·F-1673-2015·2015-04-08

    Health One Pharmaceuticals Recalls Shrink & Clean Dietary Supplement

    Health One Pharmaceuticals is recalling Shrink & Clean dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Shrink & Clean, 60 Capsules, 500mg
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1361-2015·2015-04-08

    King Systems Double Swivel Connector Recalled for Mislabeling

    King Systems Corp. is recalling 900 units of Double Swivel Connectors mislabeled as having a suction port. The error may cause a short procedure delay but poses no risk to patients.

    Product
    Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1343-2015·2015-04-08

    Microtek Medical Smoke Evacuator Tubing Recalled for Unlabeled Latex Packaging

    Microtek Medical is recalling smoke evacuator tubing because the packaging contains latex but lacks the required warning label.

    Product
    TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1653-2015·2015-04-08

    Health One Recalls True Woman Dietary Supplements for cGMP Violations

    Health One Pharmaceuticals is recalling True Woman dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    True Woman, 60 Vege Capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1374-2015·2015-04-08

    Biologic Therapies Recalls Bio-CORE Cannula Sets for Misbranding

    Biologic Therapies, Inc. is recalling Bio-CORE Cannula (Needle) Sets because they were distributed without proper FDA clearance and classification.

    Product
    Bio-CORE Cannula (Needle) Set
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-1679-2015·2015-04-08

    Health One Pharmaceuticals Recalls Griffonia Seed Extract 5-HTP Capsules

    Health One Pharmaceuticals is recalling Griffonia Seed Extract 5-HTP Capsules due to significant violations of cGMP regulations for dietary supplements.

    Product
    Griffonia Seed Extract 5-HTP Capsule, 60 capsules, 100mg
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1718-2015·2015-04-08

    Health One Pharmaceuticals Recalls Fish Oil 200 for cGMP Violations

    Health One Pharmaceuticals is recalling Fish Oil 200 dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Fish Oil 200
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1744-2015·2015-04-08

    Health One Pharmaceuticals Recalls Passion Secret Dietary Supplements

    Health One Pharmaceuticals is recalling Passion Secret dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Passion Secret
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1671-2015·2015-04-08

    Health One Pharmaceuticals Recalls Four Things Combination Dietary Supplement

    Health One Pharmaceuticals is recalling Four things Combination dietary supplements due to significant violations of current good manufacturing practices (cGMP) regulations.

    Product
    Four things Combination, 100 Vegetarian Capsules, 500mg
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1366-2015·2015-04-08

    Owen Mumford Autoject E1 Fixed Needle Device Recalled for Missing Components

    Owen Mumford USA, Inc. is recalling 3,100 Autoject E1 Fixed needle devices because the syringe carrier is missing a damper and spring.

    Product
    Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
    Category
    Medical Device
    Distribution
    Distributed nationwide